SUREFORM
Report
- Report Number
- 2955842-2024-11164
- Event Type
- Malfunction
- Date Received
- February 7, 2024
- Date of Event
- January 12, 2024
- Report Date
- January 20, 2024
- Manufacturer
- INTUITIVE SURGICAL, INC
- Product Code
- NAY
- PMA / PMN Number
- K173721
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
PLEASE REFER TO THE ANNEX F CODE.
A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.
INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE SUREFORM (SF) 60 STAPLER WAS RETURNED, AND FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED INITIALIZATION FOR THE SECOND INSTALL. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE JAWS OPENED AND CLOSED PROPERLY. THE INSTRUMENT CLAMPED, FIRED, AND UNCLAMPED SUCCESSFULLY. THE INSTRUMENT WAS FIRED WITH A SF GREEN 60 RELOAD. NO FAILURES WERE OBSERVED DURING LOG REVIEW. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE: THE INSTRUMENT FAILED MECHANICAL ENGAGEMENT WHEN PLACED IN THE SYSTEM WITH ERROR CODE 22020, ROLL HARD STOP FAILURES, FOR THE FIRST AND THIRD INSTALLS. INSTRUMENT INPUTS FAILED TO ENGAGE WITH THE STERILE ADAPTER IN MULTIPLE ATTEMPTS. A REVIEW OF THE LOGS DID NOT SHOW ANY ENGAGEMENT FAILURES. THE INSTRUMENT WAS FOUND TO HAVE A MISALIGNED ROLL GEAR. THE TOOTH ON THE ROLL GEAR WAS FOUND TO BE MISALIGNED WITH RESPECT TO THE IDLER GEAR. AS A RESULT, THE MAIN TUBE IS ABLE TO BE ROTATED PAST ITS HARD STOP. THIS FAILURE CAUSED THE ENGAGEMENT FAILURES OBSERVED. NO PHYSICAL DAMAGE TO THE GEARS WERE OBSERVED.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SUREFORM INSTRUMENT WAS CLAMPED AROUND APPENDIX IN ALMOST MAXIMUM ROTATION AND THE RELOAD CAME SLIGHTLY OFF OF ITS ORIGINAL PLACE. SUREFORM GOT STUCK IN THAT POSITION AND IT WAS IMPOSSIBLE TO OPEN THE JAWS OR STRAIGHTEN THE WRIST FROM THE SURGEON CONSOLE. BEDSIDE ASSISTANT TRIED TO ROTATE THE RELEASE KNOB, BUT NOTHING HAPPENED. THE BEDSIDE ASSISTANT FINALLY SLIDED THE APPENDIX AWAY BETWEEN THE JAWS BY USING ASSISTANT PORT AND FORCEPS. THE SUREFORM WAS TAKEN AWAY FROM THE INSTRUMENT ARM. THE APPENDIX WAS REMOVED VIA LAPAROSCOPY. CUSTOMER DID NOT USE A BACKUP INSTRUMENT/SUREFORM STAPLER. NO FRAGMENT FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY WITH NO PATIENT HARM, ADVERSE OUTCOME OR INJURY AND WITH A DELAY OF 15 TO 30 MINUTES. INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE PROCEDURE WAS CONVERTED TO TRADITIONAL LAPAROSCOPIC APPROACH AS THIS IS A NORMAL NEXT STEP IN THAT KIND OF PROCEDURE. SURGEONS UNDOCKED THE ROBOT AND PERFORMED THE PROCEDURE IN A TRADITIONAL LAPAROSCOPIC WAY BY USING THE ROBOTIC ENDOSCOPE AND TRADITIONAL LAPAROSCOPIC INSTRUMENTS. THE CONVERSION DID NOT RESULT IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS. THE PATIENT TOLERATED THE CHANGE. THERE WAS NO HARM OR INJURY TO THE PATIENT. THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND THERE WAS NO DAMAGE OR ANYTHING OUT OF THE ORDINARY OBSERVED. THE PROCEDURE BEING PERFORMED WAS LAPAROSCOPIC ROBOT ASSISTED PARTIAL PROCTECTOMY WITH TOTAL EXCISION OF MESORECTUM AND APPENDICECTOMY WAS BEING PERFORMED WITH THE INSTRUMENT WHEN THE ISSUE OCCURRED. THERE WERE NO SYSTEM FAULT ALARMS. THERE WAS NO ADVERSE EFFECT TO THE GRASPED TISSUE. THERE WAS NO UNEXPECTED TISSUE REMOVAL. A BLUE STAPLER RELOAD COLOR WAS INVOLVED WITH THE REPORTED EVENT AND THE ISSUE HAPPENED DURING THE THIRD FIRE. THE SURGEON DID NOT EXPERIENCE ANY CLAMPING ISSUES PRIOR TO FIRING THE STAPLER RELOAD. THE UNCLAMPING FAILURE OCCURRED AFTER TRYING TO FIRE THE RELOAD. NEXT STEP WAS SURGEON TAKING FOOT OFF PEDAL AND TRY TO RELEASE THE CLAMP AND STOP SQUEEZING THE MASTER TOOL MANIPULATOR (MTM), BUT THE STAPLER JAWS DIDN'T OPEN NOR STRAIGHTEN THE SUREFORM WRIST.
REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 812648 | SUREFORM | STAPLER 60 | NAY | INTUITIVE SURGICAL, INC | 480460-09 | L82230731 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | DA VINCI INSTRUMENTS AND ACCESSORIES |